Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects
NCT ID: NCT01860612
Last Updated: 2022-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2013-10-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PMA Cohort
Study participants that meet the inclusion/exclusion criteria for the study may be enrolled in the compassionate use treatment arm. The artificial iris will be implanted in the eye with an iris defect. The fellow eye can be treated 1 month after the primary eye.
Artificial Iris (CustomFlex)
Compassionate Use Cohort
Study participants that do not meet the inclusion/exclusion criteria for the study may be enrolled in the compassionate use treatment arm. The artificial iris will be implanted in the eye with an iris defect. The fellow eye can be treated 1 month after the primary eye.
Artificial Iris (CustomFlex)
Continued Access Cohort
Study participants that meet the inclusion/exclusion criteria for the study may be enrolled in the Continued Access cohort, after enrollment in the PMA cohort is complete.The fellow eye can be treated 1 month after the primary eye.
Artificial Iris (CustomFlex)
Interventions
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Artificial Iris (CustomFlex)
Eligibility Criteria
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Inclusion Criteria
1. 22 years of age or older
2. Having a diagnosis of congenital or acquired full or partial iris defect in the study eye.
3. Having symptoms of light sensitivity, photophobia, and/or glare in the study eye.
4. Subjects should be pseudophakic, aphakic or require cataract extraction.
5. Signed and received a copy of the signed written informed consent.
6. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
1. Previous AI-001 IDE study participant who was enrolled before PMA approval (i.e., before May 30, 2018) and has had the CustomFlex™ Artificial Iris implanted for 36 months or less if enrolled as an adult or for 60 months or less if enrolled as a pediatric subject.
2. Signed and received a copy of the signed written informed consent.
3. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
Pediatric subjects in whom the subject and study eye meet all of the following criteria are candidates for enrollment in the Pediatric New Enrollment Cohort:
1. Age between 3 years and less than 22 years at the time of consent for the OSB PAS.
2. Having a diagnosis of congenital or acquired full or partial iris defect in the study eye.
3. Having symptoms of light sensitivity, photophobia, and/or glare or other aniridic symptoms in the study eye.
4. Subjects should be pseudophakic, aphakic or require cataract extraction.
5. Signed and received a copy of the signed written informed consent for the OSB PAS.
6. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations.
Exclusion Criteria
1. Uncontrolled ocular inflammation (e.g., uveitis).
2. Preoperative intraocular pressure \> 21 mm Hg.
3. Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment.
4. Subjects with any of the following conditions:
1. Severe chronic uveitis
2. Microphthalmus
3. Untreated retinal detachment
4. Untreated chronic glaucoma
5. Rubella cataract
6. Rubeosis of the iris
7. Proliferative diabetic retinopathy
5. Female subjects who are pregnant or lactating at the time of surgery.
6. Subjects with a known sensitivity to required postoperative study medications (4th generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication is not available.
7. Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation.
8. Stargardt's retinopathy.
9. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative systemic steroids are required.
10. Surgical difficulty of the planned surgery, which might increase the potential for complications.
11. No useful vision or vision potential in the fellow eye.
12. Clear crystalline lens (in eyes with intact natural, crystalline lens).
13. Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks.
14. In the investigator's opinion, the presence of a condition or finding in the contralateral eye that would make it unsafe to implant a CustomFlex™ Artificial Iris prosthesis in the study eye.
All pediatric subjects in whom the subject or study eye meets any of the following criteria will be excluded from enrollment in the Pediatric New Enrollment Cohort:
1. Uncontrolled ocular inflammation (e.g., uveitis).
2. Preoperative intraocular pressure \> 21 mm Hg.
3. Subjects with a current condition that, in the investigator's opinion, would interfere with the treatment.
4. Subjects with any of the following conditions:
1. Severe chronic uveitis
2. Microphthalmus
3. Untreated retinal detachment
4. Untreated chronic glaucoma
5. Rubella cataract
6. Rubeosis of the iris
7. Proliferative diabetic retinopathy
8. Intraocular infections
5. Severe endothelial corneal dystrophy.
6. Subjects in whom an ocular surgery to treat an existing condition is planned to be performed in the study eye within 6 months after the artificial iris implant surgery day.
7. Female subjects who are pregnant or lactating at the time of surgery.
8. Subjects with a known sensitivity to required postoperative study medications (4th generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication is not available.
9. Subjects under legal guardianship or who, in the investigator's opinion, lack the mental capacity to provide written informed consent for study participation.
10. Stargardt's retinopathy.
11. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative systemic steroids are required.
12. Surgical difficulty of the planned surgery, which might increase the potential for complications.
13. No useful vision or vision potential in the fellow eye.
14. Clear crystalline lens (in eyes with intact natural, crystalline lens).
15. Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eye within the previous 4 weeks.
16. In the investigator's opinion, the presence of a condition or finding in the contralateral eye that would make it unsafe to implant a CustomFlex™ Artificial Iris prosthesis in the study eye.
3 Years
ALL
No
Sponsors
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HumanOptics AG
INDUSTRY
Clinical Research Consultants, Inc.
INDUSTRY
Responsible Party
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Locations
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Advanced Vision Care
Los Angeles, California, United States
Jules Stein Eye Institute
Los Angeles, California, United States
Woolfson Eye Institute
Atlanta, Georgia, United States
Eye Consultants of Atlanta
Atlanta, Georgia, United States
Price Vision Group
Indianapolis, Indiana, United States
Minnesota Eye Consultants
Bloomington, Minnesota, United States
The Mackool Eye Institute
Astoria, New York, United States
Rosenthal Eye Surgery
Great Neck, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Oregon Eye Associates
Eugene, Oregon, United States
Wills Eye Institute
Philadelphia, Pennsylvania, United States
Alkek Eye Center/ Baylor College of Medicine
Houston, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AI-001
Identifier Type: -
Identifier Source: org_study_id
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